AUSTIN, Texas, Nov. 19, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the Company has added Gabrail Cancer Center in Canton, Ohio, as a new clinical trial site for the Acclaim-1 and Acclaim-3 clinical trials studying its lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), in lung cancer. In addition, the Company expect ...

Core Insights - Genprex, Inc. announced positive preclinical data for Reqorsa® Gene Therapy targeting ALK-EML4 positive non-small cell lung cancer (NSCLC) [1][3][4] - The data was presented at the 2025 AACR-NCI-EORTC International Conference, highlighting the potential of Reqorsa in combination with Alectinib to improve treatment outcomes [2][3] Company Overview - Genprex is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing innovative technologies to deliver disease-fighting genes [7][9] - The company's lead product, Reqorsa, is designed to deliver the TUSC2 gene specifically to cancer cells while minimizing effects on normal tissues [6][9] Research Findings - Preclinical studies demonstrated that Reqorsa can upregulate the tumor suppressor gene TUSC2, inducing apoptosis in ALK+ NSCLC cells, including those resistant to Alectinib [4][6] - The combination of Reqorsa and Alectinib resulted in longer survival rates in mouse models compared to control groups, supporting the potential for clinical trials in ALK-positive lung cancer [3][4] Clinical Development - Reqorsa is currently being evaluated in two clinical trials for NSCLC and small cell lung cancer (SCLC), both of which have received Fast Track Designation from the FDA [9] - The SCLC program has also received Orphan Drug Designation from the FDA, indicating its potential to address unmet medical needs [9]

Core Insights - Genprex, Inc. announced positive preclinical data for its Reqorsa® Gene Therapy, indicating its potential effectiveness in treating ALK-EML4 positive non-small cell lung cancer (NSCLC) [1][2] - The therapy demonstrated a 79% tumor shrinkage rate, outperforming alectinib, which showed a 60% reduction [7] Company Overview - Genprex is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System to administer gene therapies [10] - The lead product candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), is currently being evaluated in clinical trials for NSCLC and small cell lung cancer (SCLC) [10] Research Findings - Preclinical studies showed that Reqorsa can induce apoptosis in ALK+ NSCLC cell lines and patient-derived organoids, leading to significant tumor reduction [6][8] - The combination of Reqorsa and alectinib resulted in a 23% improved outcome compared to alectinib alone, suggesting its potential as a companion drug for advanced disease [7] Upcoming Presentations - Positive preclinical data will be presented at the 2025 AACR-NCI-EROTC International Conference on Molecular Targets and Cancer Therapeutics, highlighting the efficacy of Reqorsa in NSCLC [1][3]

Market Movements - Australian Oilseeds Holdings Limited Warrant (NASDAQ:COOTW) surged by 494.86% to $0.18 with a trading volume of 3,759,243, while its ordinary shares (COOT) increased by 244.87% to $3.32 with a trading volume of 167,502,947, despite facing a Nasdaq notification regarding non-compliance with the minimum stockholders' equity requirement of $10 million [1][4] - Genprex, Inc. (NASDAQ:GNPX) saw a 193.90% increase in its stock price to $0.74 with a trading volume of 825,729,912, driven by anticipation of promising preclinical data on its Reqorsa® Gene Therapy, which targets ALK-EML4 positive translocated non-small cell lung cancer [1][4] - Omeros Corporation (NASDAQ:OMER) experienced a 170.73% increase in its stock price to $11.1 with a trading volume of 107,994,321, following a significant licensing agreement with Novo Nordisk valued at up to $2.1 billion, granting exclusive global rights to develop and commercialize Omeros' MASP-3 inhibitor [1][4] Investor Interest - Bonk, Inc. Warrant (BNKKW) experienced a 125.16% price increase to $0.17 with a volume of 127,897, indicating investor interest in the company's prospects [2] - The reasons behind these surges include positive clinical trial results, strategic corporate developments, and broader market trends favoring these sectors [2] - The market environment reflects significant investor interest across various sectors, including biotechnology and consumer defensive, with analysts closely monitoring these companies for further developments [3]

Core Viewpoint - Genprex, Inc. has received patent allowances for its lead drug candidate, Reqorsa® Gene Therapy, in combination with immune checkpoint inhibitors, enhancing its intellectual property portfolio for oncology treatments [1][2][3] Intellectual Property Developments - The U.S. Patent and Trademark Office and the European Patent Office have issued Notices of Allowance for patents covering the use of Reqorsa in combination with PD-L1 and PD-1 antibodies, respectively, with both patents set to expire in 2037 at the earliest [1][3] - Genprex has also secured patents for Reqorsa in combination with PD-L1 antibodies in Korea and is pursuing additional patent applications in Europe, Canada, Brazil, China, and Israel [3] Clinical Trial Information - The Acclaim-3 study is a Phase 1/2 clinical trial evaluating Reqorsa in combination with Genentech's Tecentriq® for patients with extensive stage small cell lung cancer (ES-SCLC) [5] - The Acclaim-3 trial has received FDA Fast Track Designation and Orphan Drug Designation, indicating its potential significance in treating this patient population [5] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing a non-viral Oncoprex® Delivery System for its gene therapies [6] - The company's lead product candidate, Reqorsa, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), both of which have received FDA Fast Track Designation [6]

Core Viewpoint - Genprex, Inc. has been selected to present its Acclaim-3 Phase 1/2 clinical trial design for Reqorsa Gene Therapy in combination with Tecentriq at the 2025 ASCO Annual Meeting, highlighting its commitment to advancing cancer treatment options [1][2]. Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing innovative technologies to deliver disease-fighting genes [3]. - The company's lead product candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), is under evaluation for treating non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [3]. - Genprex's oncology program employs a non-viral Oncoprex Delivery System, which uses lipid-based nanoparticles to encapsulate gene-expressing plasmids for intravenous administration [3]. Clinical Trial Details - The Acclaim-3 clinical trial will evaluate the combination of Reqorsa Gene Therapy and Tecentriq as maintenance therapy for extensive stage small cell lung cancer (ES-SCLC) [1][2]. - The trial design will be presented in a poster session on May 31, 2025, by Dr. Bo Wang [2]. Regulatory Designations - Genprex's lung cancer clinical programs have received Fast Track Designation from the FDA, and the SCLC program has also received Orphan Drug Designation [3].

Core Viewpoint - Genprex, Inc. announced the publication of positive preclinical data on its lead drug candidate, Reqorsa® Gene Therapy, for treating KRASG12C mutant non-small cell lung cancer (NSCLC) [1][2][3] Group 1: Research and Development - The abstract detailing the preclinical data was published in the online Proceedings supplement of Cancer Research [1] - The data will be presented at the 2025 AACR Annual Meeting, highlighting advances in cancer treatment [2][3] - The study demonstrated that TUSC2 gene therapy (REQORSA) effectively overcomes acquired resistance to sotorasib in KRASG12C mutant NSCLC mouse xenografts [4][5][6] Group 2: Mechanism and Efficacy - Acquired resistance to Lumakras® (sotorasib) presents a significant challenge in treating KRASG12C mutant NSCLC, necessitating alternative strategies [4] - TUSC2 gene therapy exhibits multifunctional activity, inhibiting downstream signaling pathways, inducing tumor cell death, and activating immune responses [4][5] - REQORSA alone showed significant antitumor efficacy, and a synergistic effect was observed when combined with sotorasib [5][6] Group 3: Product Information - Reqorsa® Gene Therapy consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles [7] - The therapy is designed to specifically target cancer cells while minimizing uptake by normal tissue, with laboratory studies showing 10 to 33 times greater uptake in tumor cells compared to normal cells [8] Group 4: Company Overview - Genprex, Inc. is focused on developing gene therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System [9] - The company’s lead product candidate, Reqorsa, is currently being evaluated in clinical trials for NSCLC and small cell lung cancer (SCLC) [9]